Recon: FDA advisers back Ardelyx kidney disease drug; UnitedHealth to offer Humira alongside biosimilars next year

ReconRecon | 17 November 2022 |  By 

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
  • U.S. FDA advisers back Ardelyx's kidney disease drug (Reuters) (Endpoints)
  • Lab-grown meat cleared for human consumption by U.S. regulator (Reuters) (FDA)
  • FDA Warns Seven Companies for Selling Dietary Supplements with Claims to Treat Cardiovascular Disease (FDA)
  • Roche gets EUA for high-throughput monkeypox test (MedtechDive) (Reuters)
  • Elizabeth Holmes’s Fraud Sentence Will Send a Message One Way or Another (NYTimes)
  • Pfizer, BioNTech start study testing next COVID-19 vaccine (BioPharmaDive)
  • Regeneron swoops in with $2B bispecifics biobucks pact for empty-handed CytomX (Fierce)
  • Cancer diagnoses lag after screenings fall during pandemic, U.S. study finds (Reuters)
  • UnitedHealth to Keep AbbVie’s Blockbuster Drug Humira Available (Bloomberg)
  • In a Republican-led House, probing science agencies tops the agenda (STAT)
In Focus: International
  • COVID pandemic led to surge in superbug infections, EU agency says (Reuters)
  • Ebola vaccine candidates expected to be shipped to Uganda next week – WHO (Reuters)
  • Britain's NICE recommends against NHS use of 5 COVID treatments as not cost-effective (Reuters)
  • NICE recommends Pfizer’s Paxlovid on NHS (PharmaTimes)
  • Takeda’s Exkivity receives NICE recommendation for rare form of lung cancer (PMLive)
  • Nearly half of world population suffers from oral diseases – WHO (Reuters)
  • German panel recommends COVID shot only for at-risk youngsters (Reuters)
  • EU secures up to 2 million monkeypox vaccine doses from Bavarian Nordic (Reuters)
  • ‘We were right all along:’ For Japanese drugmaker Eisai, success against Alzheimer’s has been a long time coming (STAT)
Pharma & Biotech
  • Lilly CEO concedes Twitter flap over insulin costs shows there’s ‘more work to do’ (STAT)
  • Doctors Are Running Out of Antibody Drugs to Treat Covid as Virus Mutates (Bloomberg)
  • Novartis considers selling its $5B+ ophthalmology and respiratory units — report (Endpoints)
  • Another day, another FDA reprimand for troubled Indian manufacturer Lupin (Fierce)
  • Editas shelves lead asset after proof-of-concept data whittles down likely patient population (Fierce) (STAT)
  • With the walls closing in for Clovis, FDA demands ovarian cancer restriction for Rubraca (Fierce)
  • Generic Sample Access Process For REMS-Protected Brands Now Includes Agency Timeline (Pink Sheet)
  • Vertex revolutionized cystic fibrosis treatment. Its executives say that’s just the start (STAT)
  • Radioisotope company moves forward with CDMO plans, breaking ground on new manufacturing site in Wisconsin (Endpoints)
  • CureVac puts lead oncology candidate on back burner and will only move it forward in combination therapies (Endpoints)
  • Emergent scores a DoD award to evaluate its chikungunya vaccine in the field (Endpoints)
  • Tenaya bags $75M from stock sale as it prepares to put a gene therapy for heart disease into the clinic (Endpoints)
  • Insulet's power problems grow with FDA battery recall, Omnipod 5 charger notice (Fierce) (FDA)
  • Medtronic’s renal denervation treatment ‘still a viable therapy’ despite study miss, doctors say (MedtechDive)
  • Exact Sciences founders raise $56M for new liquid biopsy venture (MedtechDive)
  • Speculation On Baxter Division Picks Up Steam (MedtechInsight)
  • Medtronic begins U.S. launch of 7-day insulin infusion set (Fierce)
  • EU Cyber Resilience Act Should Include Medtech, Says Data Protection Watchdog (MedtechInsight)
  • EU Medtech Industry Awaits Outcome Of MDCG’s Urgent Meeting With Bated Breath (MedtechInsight)
Government, Regulatory & Legal
  • In Pfizer Win, PTAB Says Rival's Gene Therapy Wasn't New (Law360)
  • J&J Seeks SCOTUS Review of $302 Million Fine in Pelvic Mesh Case (Bloomberg)
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is published each week on Monday, Tuesday and Thursday.
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.


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